Novel Coronavirus Neutralizing Antibody Rapid Test Kit
Manufactured by Sensing Self Pte. Ltd., Singapore - www.sensingself.me
Device identification number
2040
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Card, Cassette, Lateral flow
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Novel Coronavirus Neutralizing Antibody Rapid Test Kit is a qualitative product, not applicable to LOD
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
LOD
0 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % (377 samples are proven negative of 377 negative specimens)
False negatives
1.37 % ((2 samples are proven negative of 144 positive specimens.)
Precision
Evaluated
Accuracy
99.62 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.63 %
Clinical Specificity
99.99 %
Type of antigen
Other
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements